Senior Catheter Manufacturing Engineer (Medical Devices)

Nextern; Maple Grove (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND生日假期

Lifetime Membership Subsidy andWelln

Life Insurance (Basic, Voluntary &

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays!!!

Job summary

Nextern is seeking a Senior Manufacturing Engineer with deep hands-on expertise in catheter and balloon catheter manufacturing to lead high-risk processes and drive continuous improvement. This individual will act as a senior technical authority, mentor junior engineers, and partner with R&D during transfers to scalable production.

The role requires 7–10 years in medical device manufacturing, with a focus on balloon forming, extrusion, tipping, bonding, and related assembly operations.

Qualifications

• 7+ years in medical device manufacturing engineering with catheter/balloon experience.
• Hands-on leadership in high-risk manufacturing processes and validation.
• Experience with FDA-regulated environments and design transfers.

Responsibilities

• Lead catheter/balloon manufacturing processes including forming, extrusion, tipping, bonding and RF/laser welding.
• Design, develop and optimize complex manufacturing processes for electro-mechanical devices using DOE/DOE and lean methods.
• Own validation strategy (IQ/OQ/PQ) and equipment qualification for new and existing processes.

Skills

Catheter manufacturing

Balloon catheter manufacturing

DOE

SPC

Lean manufacturing

IQ/OQ/PQ validation

CAD software

FDA compliance

Education

Bachelor's degree in STEM

Master's degree (a plus)

Tools

Epicor ERP

SolidWorks/AutoCAD

Job description

Nextern is seeking a Senior Manufacturing Engineer with deep hands-on expertise in catheter and balloon catheter manufacturing to lead high-risk processes and drive continuous improvement. This individual will act as a senior technical authority, mentor junior engineers, and partner with R&D during transfers to scalable production.

The role requires 7–10 years in medical device manufacturing, with a focus on balloon forming, extrusion, tipping, bonding, and related assembly operations.